FDA-Drug2012-08-29Class II

CMS-8934 Custom Phlebectomy Tray, Sterile, contains Sodium chloride 0.9% 50 mL, Manufactured by: CMS, Custom Medical Specialties, Inc., 330 East Main St, PO Box 177, Pine level, NC 27568, the tray also contains other components not listed in this product description.

Custom Medical Specialties, Inc.
Hazard

Lack of Assurance of Sterility; the firm's medical trays contain Hospira's 0.9% Sodium Chloride bags which were subject to recall due to leaking bags.

Sold states
GA, MD, MA
Affected count
20 Trays
Manufactured in
330 East Main Street, N/A, Pine Level, NC, United States
Products
CMS-8934 Custom Phlebectomy Tray, Sterile, contains Sodium chloride 0.9% 50 mL, Manufactured by: CMS, Custom Medical Specialties, Inc., 330 East Main St, PO Box 177, Pine level, NC 27568, the tray also contains other components not listed in this product description.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1650-2012

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